Quality Systems Specialist - EDMS

Job description

Purpose and Scope The Quality Systems Specialist-EDMS ensures and maintains the quality system processes, including but not limited to administration and use of the Quality Management System (QMS), Electronic Document Management System (EDMS), and Electronic Learning Management System (ELMS). This position will serve as a quality representative for Veeva electronic system implementation and updates, document change controls, coordination of department documents and deviation trending. This position drives the continuous education, implementation and improvement of Quality Systems and compliance with regulations and ensures that the site's Document Processes and structure meet all business and regulatory requirements. Furthermore, this position provides guidance and assistance to ensure compliance of process procedures with applicable regulations and standards, such as, good documentation practices, quality system regulations, and organization of international standards including administrative support to the Quality organization. Essential Duties & Responsibilities: - Carry out responsibilities in accordance with the organization’s policies, procedures, and pharmaceutical/device re...